Shots:
- The US FDA has accepted NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. neonates; MAA was submitted to MHLW & EMA with further filings planned in other regions
- NDA was supported by the QUANTI clinical program, which incl. 2 P-III (QUANTI CNS & QUANTI OBR) studies as well as the QUANTI Pediatric study, enrolling 808 pts across 15 countries
- QUANTI program met its 1 & 2EPs assessing visualization & lesion detection, while QUANTI Pediatric showed similar PK in children & adults; data from QUANTI CNS was presented at ECR 2025, with further results to be shared in future meetings
Ref: Bayer | Image: Bayer | Press Release
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